BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSITE CLASSIC SYSTEM

    MDR report key: 1604414 · Received February 9, 2010

    Report

    Report Number
    2184149-2010-00002
    Event Type
    Injury
    Date Received
    February 9, 2010
    Date of Event
    January 29, 2010
    Report Date
    February 8, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DQK
    PMA / PMN Number
    K983456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN PROCESS OF INVESTIGATING THIS EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE FIELD SERVICE REPORT DATED 02/04/2010 HAD INDICATED THAT SERVICE WAS PERFORMED ON THE ENSITE CLASSIC SYSTEM AND NO PROBLEMS WERE FOUND. DATE THE INITIAL RPTR PROVIDED THE INFO TO THE MFR: 02/02/2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT ATRIAL ABLATION, A DUAL TRANSEPTAL PUNCTURE WAS PERFORMED. DURING THE ABLATION, THERE WAS A SHIFT ON THE CARTOGRAPHY FOR THE RIGHT PULMONARY VEIN AND FOR THE LEFT PULMONARY VEIN. THERE WAS A PERICARDIAL EFFUSION AND A TAMPONADE. THE SHIFT WAS NOT VISIBLE ON THE COMPACT DISK (CD) AS A RECORDING WAS NOT PERFORMED. AN ENGUIDE ALIGNMENT WAS PERFORMED BUT THE PHYSICIAN SAID THAT THE EVENT OCCURRED BEFORE THE ALIGNMENT WHEN THE SHIFT WAS PRESENT. A PERICARDIOCENTESIS. WAS PERFORMED TO RESOLVE THE EFFUSION. THE PHYSICIAN ALLEGED THAT THE PRECISION OF THE TRIDIMENSIONAL CARTOGRAPHY CAUSED THE PERFORATION. A BRK XS TRANSSEPTAL NEEDLE ((B) (4), LOT 2896703) AND THREE IBI DEVICE, STEERABLE DIAGNOSTIC CATHETER ((B) (4), LOT K15843), OPTIMA STEERABLE DIAGNOSTIC CATHETER ((B) (4), LOT K21484) AND A COOL PATH DUO ABLATION CATHETER ((B) (4), LOT NUMBER K21320) WERE USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSITE CLASSIC SYSTEM ENSITE CLASSIC SYSTEM DQK ST. JUDE MEDICAL EE3000 958

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other